GARDASIL® 9, New HPV Vaccine from Sanofi Pasteur MSD Granted Positive Opinion by European Committee for Medicinal Products for Human Use

Lyon, France (ots/PRNewswire) -

European Committee for Medicinal Products for Human Use (CHMP)
granted

positive opinion for GARDASIL 9, the first 9-valent HPV vaccine

Sanofi Pasteur MSD today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted this week a positive opinion recommending
the marketing authorisation for GARDASIL 9, a 9-valent HPV vaccine,
for active immunization of females and males from the age of 9 years
against premalignant lesions and cancers affecting the cervix, vulva,
vagina and anus caused by vaccine HPV types and genital warts
(Condyloma acuminata) caused by specific HPV types.

To view the Multimedia News Release, please click:

http://www.multivu.com/players/English/7483651-gardasil9-vaccine-s
anofi-pasteur

The CHMP's positive opinion comes after the recent approval of
GARDASIL 9 granted by the Food and Drug Administration (FDA, USA).

"We anticipate that, if approved, GARDASIL 9 will represent a
major step forward in HPV prevention. GARDASIL 9 has the potential to
help prevent over 80% of genital cancers caused by HPV and to reduce
the transmission of the 9 HPV types" said Dr Jean-Paul Kress,
President of Sanofi Pasteur MSD. "We are delighted that the CHMP has
recommended marketing authorisation for GARDASIL 9 and we are looking
forward to the European Commission decision," he concluded.

GARDASIL 9 includes the greatest number of HPV types in any
available HPV vaccine. The seven high-risk HPV types in GARDASIL 9
(HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90% of
cervical cancer cases and approximately 80% of high-grade cervical
lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS)
worldwide. The 2 remaining types, HPV 6 and 11, cause 90% of genital
wart cases.

The CHMP opinion was granted following review of the results from
a comprehensive clinical program that began in 2007 and included
seven trials that evaluated more than 15,000 individuals in more than
11 countries.

Video:
http://www.multivu.com/players/English/7483651-gardasil9-vaccine-sanofi-pasteur

ots Originaltext: Sanofi Pasteur MSD GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Sylvia Martin-Jarrand, Sanofi Pasteur MSD, Tel:
+33-4-37-28-40-55, Mob: +33-6-74-85-19-63, smartin-jarrand@spmsd.com